Question { Wockhardt, 67661 }

what is the major definition and difference between
uniformity of content and content uniformity as official
test for all tablets?

Answer

As per USP general chapter <905>, to ensure the consistency
of dosage units uniformity of dosage unit test is
performed. The term “uniformity of dosage unit” is defined
as the degree of uniformity in the amount of the drug
substance among dosage units. It can be demonstrated by
either of two methods:

1. Weight variation: Applicable to Solutions enclosed in
unit-dose containers and into soft capsules, powders,
granules, and sterile solids that are packaged in single-
unit containers, Hard capsules, uncoated tablets, or film-
coated tablets.

2. Content Uniformity: is required for all dosage forms not
meeting the above conditions like suspensions, emulsions,
or gels in unit-dose containers. Drus substance present in
lesser proportions less tahn 25 mg.

Question { Lupin, 8999 }

Explain photostability ?

Answer

As per ICH Q1B guideline photostability is performed to
evaluate the light exposure does not result in unacceptable
change or to demonstrate intrinsic photostability
characteristics of new drug substances and products.

The photo stability testing should be carried out on at
least one primary batch of the drug product.

Question { Glenmark, 56703 }

What is the limit for friability of tablets?

Answer

Friability test is used to determine the physical strength
or tablet breaking force for compressed, uncoated tablets.

Tablet Friability Apparatus is used for the test. Remove
any loose dust from the tablets and accurately weigh 10
tablets. They are placed in the drum which rotates at 25±1
rpm. Rotate the drum 100 times, and remove the tablets.

The sample fails the test, if any of the 10 tablets
cracked, cleaved, or broken is present. If the weight loss
is more than 1.0%, the test is repeated for twice and the
mean of three tests is calculated. The mean not more than
1.0% is considered acceptable.

Please note that for Effervescent tablets and chewable
tablets the friability limits may differ.

Question { 16478 }

What should be the sampling point in dissolution test?

Answer

There is no specific recommendation for sampling in
dissolution test. It is recommended that a specimen should
be withdraw from a zone midway between the surface of the
Dissolution Medium and the top of the rotating basket or
blade, not less than 1 cm from the vessel wall.

Where multiple sampling times are specified, replace the
aliquots withdrawn for analysis with equal volumes of fresh
Dissolution Medium at 37°C or, where it can be shown that
replacement of the medium is not necessary, correct for the
volume change in the calculation.

Specimens are to be withdrawn only at the stated times
within a tolerance of ± 2%.

Question { 11342 }

What is photo stability?

Answer

Many pharmaceutical substances undergo changes in presence
of light. Photo stability study is performed to evaluate
and demonstrate that light exposure does not result in
unacceptable change in new drug substances and products.
Mostly the testing is carried out on a single batch of API
or product. If any changes or variation is done in current
product like change in formulation or packing these study
should be repeated. Wheatear the study should be repeated
or not depends upon the initial results of photostability
study.

Question { 10578 }

Why we use disodium tartare for determination of factor in
karl ficher titration?

Answer

Karl Fischer titration method is used to for the
titrimetric determination of water in samples. Because of
KF reagent undergoes the slow deterioration, the reagent
has to be standardized frequently, before going for the
water determination in sample.

Disodium tartrate is used as a primary standard substance
for the standardization because of the following properties:

1. Available in a stable crystalline hydrate form
2. Its water content is close to theoretical value
3. Substances in nearly 100% purity
4. More favorable gravimetric factors
5. Stable at extreme humidities
6. It is relatively insoluble in absolute methanol
7. Its water content is rapidly and quantitatively titrated
to a sharp end point

Question { 6719 }

In KF Standardization why we use Disodium Tartarate?

Answer

Karl Fischer titration method is used to for the
titrimetric determination of water in samples. Because of
KF reagent undergoes the slow deterioration, the reagent
has to be standardized frequently, before going for the
water determination in sample.

Disodium tartrate is used as a primary standard substance
for the standardization because of the following properties:

1. Available in a stable crystalline hydrate form
2. Its water content is close to theoretical value
3. Substances in nearly 100% purity
4. More favorable gravimetric factors
5. Stable at extreme humidities
6. It is relatively insoluble in absolute methanol
7. Its water content is rapidly and quantitatively titrated
to a sharp end point

Question { 9850 }

what is stationary phase

Answer

In chromatography, Stationary phase is responsible for the
separation of compounds from mixture. Depending upon the
stationary phase chromatography is classified as:

Phase Stationary Phase Mobile phase
Normal: Polar Non polar
Reverse: Non polar Polar

Generally Reverse phase chromatograpy is used for analysis
as well as separation.

Question { Alembic, 7359 }

What are the significance of MKT in stability study.

Answer

MKT or Mean Kinetic Temperature provides a better
representation of the effects of temperature change on
sensitive materials such as pharmaceuticals during storage
and distribution. MKT can be calculated from a series of
temperatures. It differs from arithmetic mean in that
higher temperatures are given greater weight in computing
the average.

MKT calculation gives increased weighting to higher
temperature excursions than normal arithmetic methods,
recognizing the accelerated rate of thermal degradation of
materials at higher temperatures. It expresses the
cumulative thermal stress experienced by a product at
varying temperatures during storage and distribution.

As defined by the USP, it is a “single calculated
temperature at which the total amount of degradation over a
particular period is equal to the sum of the individual
degradations that would occur at various temperatures”.

As defined by ICH, “A single derived temperature that, if
maintained over a defined period of time, affords the same
thermal challenge to a drug substance or drug product as
would be experienced over a range of both higher and lower
temperatures for an equivalent defined period.”

The mean kinetic temperature is higher than the arithmetic
mean temperature and takes into account the Arrhenius
equation.